MAUDE Adverse Event Report: QUEST MEDICAL, INC. LACRICATH BALLOON CATHETER; DCP213-BIT

Lot Number 63862

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

Quest is pending the return of the affected device for investigation.Quest will submit a follow-up report with any additional information at the conclusion of the investigation.

Event Description

A report was received from a customer regarding an alleged issue which occured during use of the device.The report states that the duct balloon of the catheter ruptured, filling the nasopharynx with sterile saline.The saline was suctioned out of the nasopharynx by the physician.

Event Description

A report was received from a customer regarding an alleged issue which occured during use of the device.The report states that the duct balloon of the catheter ruptured, filling the nasopharynx with sterile saline.The saline was suctioned out of the nasopharynx by the physician.

Manufacturer Narrative

The complaint sample was evaluated and the balloon was confirmed to have a vertical tear on the third band that resulted in the leaking.A definitive root cause for the reported complaint condition could not be determined, but it is assumed that balloon came in contact with the surgeon's instruments or a bony structure in the nasal passage, leading to the puncture.Quest will continue to monitor complaint trends for this complaint condition.

• Brand Name: LACRICATH BALLOON CATHETER
• Type of Device: DCP213-BIT
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326311
• MDR Report Key: 13022413
• MDR Text Key: 284287271
• Report Number: 1649914-2021-00008
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 63862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White